Title |
A randomized, multinational, noninferiority, phase III trial to evaluate the safety and efficacy of BF‐200 aminolaevulinic acid gel vs. methyl aminolaevulinate cream in the treatment of nonaggressive basal cell carcinoma with photodynamic therapy
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Published in |
British Journal of Dermatology, May 2018
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DOI | 10.1111/bjd.16441 |
Pubmed ID | |
Authors |
C.A. Morton, R. Dominicus, P. Radny, T. Dirschka, A. Hauschild, U. Reinhold, R. Aschoff, M. Ulrich, S. Keohane, S. Ekanayake‐Bohlig, S. Ibbotson, R. Ostendorf, C. Berking, D. Gröne, H.J. Schulze, H.M. Ockenfels, V. Jasnoch, H. Kurzen, M. Sebastian, H. Stege, P. Staubach, G. Gupta, F. Hübinger, I. Ziabreva, B. Schmitz, A. Gertzmann, H. Lübbert, R.‐M. Szeimies |
Abstract |
Basal cell carcinoma (BCC) represents the most common non-melanoma skin cancer worldwide affecting mainly adult, fair-skinned individuals. The WHO distinguishes aggressive and non-aggressive forms of which prototypical variants of the latter are primary nodular and superficial BCC. To demonstrate non-inferiority of BF-200 ALA (a nanoemulsion gel containing 5-aminolaevulinic acid) compared to MAL (a cream containing methyl-aminolevulinate) in the treatment of non-aggressive BCC with photodynamic therapy (PDT). Non-inferiority of the primary efficacy variable (overall patient complete response 12 weeks after last PDT) would be declared if the mean response for BF-200 ALA was no worse than that for MAL, within a statistical margin of Δ = -15%. The study was a randomized, phase III trial performed in Germany and the UK with ongoing 5-year follow-up. Of 281 randomized patients, 138 were treated with BF-200 ALA, 143 with MAL. Patients received two PDT sessions one week apart. Remaining lesions 12 weeks after the second PDT were retreated. Illumination was performed with a red light source (635 nm, 37 J/cm2 ). Results shown include clinical endpoints as well as patients' reassessment 12 months after the last PDT. Of the BF-200 ALA-treated patients, 93.4% were complete responders compared to 91.8% in the MAL group. The difference of means was 1.6 with a one-sided 97.5% CI of -6.5, establishing non-inferiority (p<0.0001). Results for secondary efficacy parameters were in line with the primary outcome. Recurrence rates 12 months after the last treatment were ≤ 10%. Treatment of non-aggressive BCC with BF-200 ALA-PDT is highly effective and well tolerated with proven non-inferiority to MAL-PDT and demonstrates low recurrence rates after 1-year follow-up. This article is protected by copyright. All rights reserved. |
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Geographical breakdown
Country | Count | As % |
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United Kingdom | 2 | 50% |
Norway | 1 | 25% |
Unknown | 1 | 25% |
Demographic breakdown
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Science communicators (journalists, bloggers, editors) | 2 | 50% |
Scientists | 1 | 25% |
Members of the public | 1 | 25% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 54 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Bachelor | 7 | 13% |
Researcher | 6 | 11% |
Student > Master | 4 | 7% |
Student > Ph. D. Student | 3 | 6% |
Other | 2 | 4% |
Other | 8 | 15% |
Unknown | 24 | 44% |
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Pharmacology, Toxicology and Pharmaceutical Science | 4 | 7% |
Biochemistry, Genetics and Molecular Biology | 2 | 4% |
Chemistry | 2 | 4% |
Psychology | 1 | 2% |
Other | 5 | 9% |
Unknown | 29 | 54% |